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The EU has up-ended its rules and replaced the current three directives with two new regulations that are much tougher and promise to transform the way manufacturers do business abroad. FDAnews has teamed up with Ombu Enterprises Inc. to present a two-day workshop that brings manufacturers current with all the new rules and readies them to comply before the MDR and IVDR take effect.
Falls Church, VA (PRWEB) June 23, 2017
NOTE: There are a limited number of seats available for the workshop.
The EU has up-ended its device rules.
The Medical Device Regulation (MDR), which replaces the existing Medical Device Directive (MDD), is packed with new provisions, changes to existing ones, inclusions and exclusions. These changes include:
And this barely scratches the surface.
Here’s how to cope.
Come to Boston July 11-12 for two intense days of:
In a special workshop feature, attendees will apply the MDR’s new provisions to one of their own products that currently has the CE Mark under the MDD (especially Annex II) and satisfies the U.S. UDI rule.
Workshop leader, Dan O’Leary of Ombu Enterprises LLC, is a favorite of thousands of conference attendees for his ability to simplify the most complex device-related topics.
Meet the Presenter:
Dan O’Leary, President, Ombu Enterprises, LLC
Dan has more than 30 years’ experience in quality, operations and program management in regulated industries including, aviation, defense, medical devices and clinical labs. Dan is now President of Ombu Enterprises, LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Masters Degree in Mathematics; is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Who Should Attend:
Understanding and Implementing EU Medical Device Regulation
**Presented by FDAnews and Ombu Enterprises**
July 11-12, 2017, Cambridge, MA
A limited number of seats are still available.
Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
For the original version on PRWeb visit: http://www.prweb.com/releases/FDAnews/eumdregulations/prweb14449946.htmNEXT ARTICLE
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